MAUDE Adverse Event Report: CAREFUSION SD ALARIS ETCO2 MODULE; PUMP, INFUSION

Model Number 8300

Device Problem Contamination (1120)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Although requested, the affected device has not been received.A follow up report will be submitted with investigation results should the device be received for evaluation.

Event Description

It was reported that there were issues due to fluid ingress for these 8300 devices."while they were working they began to put aside modules with corrosion and lamination issues with the keypads." customer confirmed no patient involvement.

• Brand Name: ALARIS ETCO2 MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: shari lynn groth ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 11250438
• MDR Text Key: 234020470
• Report Number: 2016493-2021-18582
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8300
• Device Catalogue Number: 8300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1